The policies, guidelines,
terms, and conditions of the HHS Centers for Disease Control and Prevention
(CDC) stated in this announcement might differ from those used by the HHS
National Institutes of Health (NIH). If written guidance for completing
this application is not available on the CDC website, then CDC will direct
applicants elsewhere for that information.

Authority:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency Review. Awards are made under the authorization of the
Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29
USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a),
30 USC 951(a); Section 301 of the Public Health Service Act as amended (42 USC
241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants Policy Statement.

Announcement Type
Reissue:
Type This Funding Opportunity Announcement (FOA) is a reissue of PAR-06-552. Update: The following update relating to this announcement has been issued:

October 12, 2011 - See Notice NOT-OH-11-004. The purpose of this Notice is to correct language in the Appendix Materials.

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

December 29, 2009 -
This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

NOTICE: Applications submitted in response to this
Funding Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://grants.gov/) using the SF424 Research and
Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED
IN PAPER FORMAT.

This FOA must be read in conjunction with the
application guidelines included with this announcement in (hereafter called Grants.gov/Apply).

A registration process is necessary before submission
and applicants are highly encouraged to start the process at least four (4)
weeks prior to the grant submission date. See Section IV.

The
National Institute for Occupational Safety and Health (NIOSH) within the
Centers for Disease Control and Prevention (CDC) invites grant applications for
research related to occupational safety and health.

Purpose. The
purpose of this grants program is to develop an understanding of the risks and
conditions that are associated with occupational diseases and injuries, to
explore methods for reducing risks and for preventing or minimizing exposure to
hazardous conditions in the workplace, and to translate significant scientific
findings into prevention practices and products that will effectively reduce
work-related illnesses and injuries.

Mechanism of Support. This FOA
will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in
parallel with NIOSH’s R01 and R03 mechanisms which have identical scientific
scope.

Funds Available and Anticipated
Number of Awards. Because the nature and scope of the proposed activities
will vary from application to application, it is anticipated that the size and
duration of each award will also vary. The total amount awarded and the number
of awards will depend upon the number of applications, quality, duration, and
costs of the applications received.

Budget and Project Period. The
total project period for an application
submitted in response to this funding opportunity may not exceed two years.
Direct costs are limited to $275,000 over an R21 two-year period, with no more
than $200,000 in direct costs allowed in any single year. The R21 is not renewable.

Eligible Project Directors/Principal
Investigators (PDs/PIs). Include Individuals with the skills,
knowledge, and resources necessary to carry out the proposed research are
invited to work with their institution/organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIOSH
support.

Number of PDs/PIs. More than
one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.

Number of Applications. Applicants may submit more than one application, provided that each application
is scientifically distinct.

Resubmissions.
Applicants may submit a resubmission application, but such application must
include an Introduction addressing the previous peer review critique (Summary
Statement).

Renewals. Exploratory/developmental grant support is for new projects only; competing
renewal (formerly “competing continuation”) applications will not be accepted.

Each
day, approximately 200 million U.S. workers go to work with the expectation
that they will return home healthy and safe. However, the workplace
environment has a significant impact on a worker’s physical and psychological
health. Depending on the job, a worker may be at risk for many different kinds
of injuries and illnesses. Recent estimates are that 9,000 workers sustain
disabling injuries every day, and that 16 workers die each day from an injury
suffered on the job while another 137 die from diseases they suffer as the
result of their current or former occupations. Such statistics translate into
tremendous economic costs and societal burdens. In addition to the personal and
social consequences, work-related injuries and illnesses result in a
significant economic burden to employers. The Liberty Mutual 2005
Workplace Safety Index estimates that employers spent $50.8 billion in 2003 on
wage payments and medical care for workers hurt on the job. All of these
figures may be significantly underestimated given that many illnesses and
diseases such as cancer, diabetes, heart disease, and asthma are only now
becoming recognized as being associated with occupational exposures that
occurred in the past.

The evolution and vitality of the
biomedical sciences require a constant infusion of new ideas, techniques, and
points of view. These may differ substantially from current thinking or
practice and may not yet be supported by substantial preliminary data. By
using the R21 mechanism, the NIOSH seeks to foster the introduction of novel
scientific ideas, model systems, tools, agents, targets, and technologies that
have the potential to substantially advance biomedical research.

The R21 mechanism is intended to
encourage new exploratory and developmental research projects. For example,
such projects could assess the feasibility of a novel area of investigation or
a new experimental system that has the potential to enhance health-related
research. Another example could include the unique and innovative use of
an existing methodology to explore a new scientific area. These studies
may involve considerable risk but may lead to a breakthrough in a particular
area, or to the development of novel techniques, agents, methodologies, models,
or applications that could have a major impact on a field of biomedical,
behavioral, or clinical research.

Applications for R21 awards
should describe projects distinct from those supported through the traditional
R01 mechanism. For example, long-term projects, or projects designed to
increase knowledge in a well-established area, will not be considered for R21
awards. Applications submitted under this mechanism should be exploratory and
novel. These studies should break new ground or extend previous
discoveries toward new directions or applications. Projects of limited
cost or scope that use widely accepted approaches and methods within well
established fields are better suited for the R03 small grant mechanism. Information
on the R03 program can be found at http://grants.nih.gov/grants/guide/pa-files/PAR-09-138.html.

Research
Objectives

In 1996, NIOSH and its partners
in the public and private sectors developed the NORA to provide a framework to
guide occupational safety and health research into the next decade.
Approximately 500 organizations and individuals outside NIOSH provided input
into the development of NORA. The agenda identifies 21 research priorities and
reflects an attempt to consider both current and emerging needs. The priority
areas were not ranked; each is considered to be of equal importance. Potential
applicants may obtain a copy of the "National Occupational Research
Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the National
Institute for Occupational Safety and Health, telephone (800) 356-4674 or on
the internet at http://www.cdc.gov/niosh/nora/ (click on “About NORA” and “first agenda”)

Objectives of research supported
by NIOSH include, but are not limited to: (1) identify and investigate the
relationships between hazardous working conditions and associated occupational
diseases and injuries; (2) develop more sensitive means of evaluating hazards
at work sites, as well as methods for measuring early markers of adverse health
effects and injuries; (3) develop new protective equipment, engineering control
technology, and work practices to reduce the risks of occupational hazards; (4)
evaluate the technical feasibility or application of a new or improved
occupational safety and health procedure, method, technique, or system.

The goal of the NIOSH research
program is to support research that is relevant, of high quality, and
demonstrates impact in reducing occupational disease and injury. Emphasis is
placed on research projects that address needs in NORA. In 2006, NIOSH is
extending NORA for another ten years with a shift in organization of the
research portfolio to reflect the industries in which workers are employed. In
that context, NIOSH created a Program Portfolio to broadly guide activities by
categorizing programs into eight (8) NORA Sector Programs that represent groups
of industrial sectors, and twenty-four (24) cross-sector programs organized
around adverse health outcomes, statutory programs and global efforts. http://www.cdc.gov/niosh/programs/

The NIOSH Program Portfolio is outlined
below:

NORA Sector Programs

Agriculture, Forestry & Fishing

Construction

Healthcare & Social Assistance

Manufacturing

Mining (including Oil and Gas Extraction)

Public and Private Services

Trade

Transportation, Warehousing & Utilities

NIOSH Cross-Sector Programs

Authoritative Recommendations Development

Cancer, Reproductive, Cardiovascular, Neurological & Renal
Diseases

Communications & Information Dissemination

Economics

Engineering Controls

Emergency Preparedness/Response

Exposure Assessment

Global Collaborations

Health Hazard Evaluation (HHE)

Hearing Loss Prevention

Immune/Dermal/Infectious Diseases

Musculoskeletal Disorders

Nanotechnology

Occupational Health Disparities

Personal Protective Technology

Prevention through Design

Radiation Dose Reconstruction

Research to Practice

Respiratory Diseases

Small Business Assistance and Outreach

Surveillance

Training Grants

Traumatic Injury

Worklife Initiative

Work Organization & Stress-Related Disorders

Applicants should provide a statement about which industry sector,
cross-sector, and emphasis area (if applicable) are being addressed and a
rationale for how the proposal will contribute to the specified priority area
(this information should be placed in the "Background and Significance"
section of the "Research Plan" of the application).

In addition to NORA, NIOSH has initiated a Research to Practice
(r2P) initiative to reduce or eliminate occupational disease and injury by
increasing the use and translation of effective NIOSH-funded research findings
in the workplace and through stakeholder involvement in the research process.
Therefore, applications should include an explanation of how their proposed
research will contribute to this initiative. Information is available at: http://www.cdc.gov/niosh/r2p/.

This FOA will use the NIH Exploratory/Developmental Research Grant
(R21) award mechanism. The Project Director/Principal Investigator (PD/PI) will
be solely responsible for planning, directing, and executing the proposed
project.

Because the nature and scope of the proposed research will vary
from application to application, it is anticipated that the size and duration
of each award will also vary. Although the financial plans of the National
Institute for Occupational Safety and Health provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications.

The total project period for an
application submitted in response to this funding opportunity may not exceed 2
years. Although the size of award may vary with the scope of research proposed,
it is expected that applications will stay within the budgetary guidelines for
an exploratory/developmental project; direct costs are limited to $275,000 over
an R21 two-year period, with no more than $200,000 in direct costs allowed in
any single year.. NIOSH grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this
FOA.

Any individual(s) with the
skills, knowledge, and resources necessary to carry out the proposed research
as the PD/PI is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIOSH support.

More than one PD/PI (i.e., multiple PDs/PIs), may be
designated on the application for projects that require a “team science”
approach and therefore clearly do not fit the single-PD/PI
model. Additional information on the implementation plans and policies and
procedures to formally allow more than one PD/PI on individual research
projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a
single PD/PI or multiple PDs/PIs grant is the responsibility of the
investigators and applicant organizations and should be determined by the
scientific goals of the project. Applications for grants with multiple PDs/PIs
will require additional information, as outlined in the instructions below. The
NIOSH review criteria for approach, investigators, and environment have been
modified to accommodate applications involving either a single PD/PI or
multiple PDs/PIs. When considering the multiple PD/PI option, please be aware
that the structure and governance of the PD/PI leadership team as well as the
knowledge, skills and experience of the individual PDs/PIs will be factored
into the assessment of the overall scientific merit of the application.

Multiple PDs/PIs on a project
share the authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please see http://grants.nih.gov/grants/multi_pi.

Number of
Applications. Applicants may submit more than one application, provided each
application is scientifically distinct.

Resubmissions.Applicants may submit one resubmission, but such application must
include an Introduction addressing issues raised in the previous critique
(Summary Statement). See NOT-OD-03-041,
May 7, 2003.

Renewals.Exploratory/developmental grant support is for new
projects only; competing renewal (formerly “competing continuation”)
applications will not be accepted.

To download a SF424 (R&R) Application Package and SF424
(R&R) Application Guide for completing the SF424 (R&R) forms for this
FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/and follow the directions provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the steps
of the registration process could take four weeks or more. Therefore,
applicants should immediately check with their business official to determine
whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must
be complete by the submission deadline for the application to be considered
“on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is
required for institutions/organizations at both:

If your organization does not have a Taxpayer Identification
Number (TIN) or Employer Identification Number (EIN), allow for extra time. A
valid TIN or EIN is necessary for CCR registration.

The CCR also validates the EIN against Internal Revenue Service
records, a step that will take an additional one to two business days
Direct questions regarding Grants.gov registration to:Grants.gov Customer
Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov

The individual designated as the PD/PI on the application must
also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to
register with Grants.gov.

The PD/PI must hold a PD/PI account in the Commons and must be
affiliated with the applicant organization. This account cannot have any other
role attached to it other than the PD/PI.

This registration/affiliation must be done by the Authorized
Organization Representative/Signing Official (AOR/SO) or their designee who is
already registered in the Commons.

Both the PD/PI and AOR/ SO need separate accounts in the NIH eRA
Commons since both are authorized to view the application image.

Note: The registration
process is not sequential. Applicants should begin the registration processes
for both Grants.gov and eRA Commons as soon as their organization has obtained
a DUNS number. Only one DUNS number is required and the same DUNS number must
be referenced when completing Grants.gov registration, eRA Commons registration
and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF 424 (R&R) Application Guide for this FOA through grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA
can be used. You will not be able to use any other SF424 (R&R) forms (e.g.,
sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.

The SF424 (R&R) Application Guide is critical to submitting a
complete and accurate application to NIOSH. There are fields within the SF424
(R&R) application components that, although not marked as mandatory, are
required by NIOSH (e.g., the “Credential” log-in field of the “Research &
Related Senior/Key Person Profile” component must contain the PD/PI’s assigned
eRA Commons User ID). Agency-specific instructions for such fields are clearly
identified in the Application Guide. For additional information, see “Frequently
Asked Questions – Application Guide, Electronic Submission of Grant
Applications.”

The SF424 (R&R) application is comprised
of data arranged in separate components. Some components are required, others
are optional. The forms package associated with this FOA in Grants.gov/Applywill include all
applicable components, required and optional. A completed application in
response to this FOA will include the following components:

When multiple PDs/PIs are
proposed, NIOSH requires one PD/PI to be designated as the "Contact” PI,
who will be responsible for all communication between the PDs/PIs and the NIH,
for assembling the application materials outlined below, and for coordinating
progress reports for the project. The contact PD/PI must meet all eligibility
requirements for PD/PI status in the same way as other PDs/PIs, but has no
other special roles or responsibilities within the project team beyond those
mentioned above.

Information for the Contact PD/PI
should be entered on the SF424 (R&R) Cover component. All other
PDs/PIs should be listed in the Research & Related Senior/Key Person
component and assigned the project role of “PD/PI.” Please remember that
all PDs/PIs must be registered in the eRA Commons prior to application
submission. The Commons ID of each PD/PI must be included in the
“Credential” field of the Research & Related Senior/Key Person
component. Failure to include this data field will cause the application
to be rejected.

Multiple PD/PI Leadership Plan: For
applications designating multiple PDs/PIs, a new section of the research plan,
entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for
choosing a multiple PD/PI approach should be described. The governance and
organizational structure of the leadership team and the research project should
be described, and should include communication plans, process for making
decisions on scientific direction, and procedures for resolving
conflicts. The roles and administrative, technical, and scientific
responsibilities for the project or program should be delineated for the
PDs/PIs and other collaborators.

If budget allocation is planned,
the distribution of resources to specific components of the project or the
individual PDs/PIs should be delineated in the Leadership Plan. In the event
of an award, the requested allocations may be reflected in a footnote on the
Notice of Award (NoA).

Applications Involving a Single
Institution

When all PDs/PIs are within a single
institution, follow the instructions contained in the SF424 (R&R)
Application Guide.

Applications Involving Multiple
Institutions

When multiple institutions are involved, one
institution must be designated as the prime institution and funding for the
other institution(s) must be requested via a subcontract to be administered by
the prime institution. When submitting a detailed budget, the prime institution
should submit its budget using the Research & Related Budget
component. All other institutions should have their individual budgets
attached separately to the Research & Related Subaward Budget Attachment(s)
Form. See Section 4.8 of the SF424 (R&R) Application Guide for further
instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime
institution completes the PHS398 Modular Budget component
only. Information concerning the consortium/subcontract budget is provided
in the budget justification. Separate budgets for each consortium/subcontract
grantee are not required when using the Modular budget format. See Section 5.4
of the Application Guide for further instruction regarding the use of the
PHS398 Modular Budget component.

Applications submitted to NIOSH are processed through NIH. To
submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply/ and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date
and must be successfully received by Grants.gov no later than 5:00
p.m. local time(of the applicant institution/organization) on the
application due date(s). (See SectionIV3A for all
dates.) If an application is not submitted by the due date(s) and time, the
application may be delayed in the review process or not reviewed. PAPER APPLICATIONS
WILL NOT BE ACCEPTED.All
attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be used.

3.C.1
Submitting On-Time

Applications may be submitted on or after the
opening date and must be
successfully received by Grants.gov no later than 5:00
p.m. local time (of the applicant
institution/organization) on the application due date(s). (See Section IV.3.A. for all
dates.) If an application is not
submitted by the due date(s) and time, the application may be delayed in the
review process or not reviewed. All applications must meet the following
criteria to be considered “on-time”:

All
registrations must be complete prior to the submission deadline

The
application must receive a Grants.gov tracking number and timestamp (or eRA
help desk ticket confirming a system issue preventing submission) by 5:00 p.m.
local time on the submission deadline date.

Any
system identified errors/warnings must be corrected and the submission process
completed within the “error correction window.”

Submission to Grants.gov is not the last step –
applicants must follow their application through to the eRA Commons to check
for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA
Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an application package has
been successfully submitted through Grants.gov, NIOSH and the NIH provides
applicants a two day error correction window to correct any eRA
identified errors or warnings before the assembled application has been created
in the eRA Commons. The standard error correction window is two (2) business
days, beginning the day after the submission deadline and excluding weekends
and standard federal holidays. All errors must be corrected to successfully
complete the submission process. Warnings will not prevent the application from
completing the submission process.,

Please note that the following
caveats apply:

Initial
application submission must be “on-time.”

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that
includes additional changes.

Proof of
“on-time” submission (e.g., Grants.gov timestamp and tracking number) and
description of all changes made within the window must be documented in the PHS
398 Cover Letter component of the application.

3.C.3 Viewing an Application in
the eRA Commons

Once any eRA identified erros
have been addressed and the assembled application has been created in the eRA Commons,
the PD/PI and the Authorized Organization Representative/Signing Official
(AOR/SO) have two seekdays (Monday – Friday, excluding Federal holidays) to
view the assembled application before it automatically moves forward for
further processing.

If everything is acceptable, no further action is necessary. The
application will automatically move forward to the Division of Receipt and
Referral in the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior to the submission deadline, the AOR/SO can “Reject” the
assembled application and submit a changed/corrected application within the
two-day viewing window. This option should be used if it is determined that
some part of the application was lost or did not transfer correctly during the
submission process, the AOR/SO will have the option to “Reject” the application
and submit a Changed/Corrected application. In these cases, please contact the
eRA Help Desk to ensure that the issues are addressed and corrected. Once
rejected, applicants should follow the instructions for correcting errors in
Section 2.12 of the SF 424 (R&R) application guide, including the
requirement for cover letters on late applications. The “Reject” feature should
also be used if you determine that warnings are applicable to your application
and need to be addressed now. Remember, warnings do not stop further
application processing. If an application submission results in warnings (but
no errors), it will automatically move forward after two weekdays if no action
is taken. Some warnings may need to be addressed later in the process.

If the two-day window falls after the submission deadline, the
AOR/SO will have the option to “Reject” the application if, due to an eRA
Commons or Grants.gov system issue, the application does not correctly reflect
the submitted application package (e.g., some part of the application was lost
or didn’t transfer correctly during the submission process). The AOR/SO should
first contact the eRA Commons Helpdesk to
confirm the system error, document the issue, and determine the best course of
action. NIH will not penalize the applicant for an eRA Commons or Grants.gov
system issue.

If the AOR/SO chooses to “Reject” the image after the submission
deadline for a reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
Late Policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will receive e-mail notifications when
the application is rejected or the application automatically moves forward in
the process after two days.

Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from
Grants.gov and the Commons. The
submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the
PI receive Commons acknowledgments. Information related to the assignment of an
application to a Scientific Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their application status in the Commons.

NIOSH will not accept any
application in response to this FOA that is essentially the same as one
currently pending initial merit review unless the applicant withdraws the
pending application. NIOSH will not accept any application that is essentially
the same as one already reviewed. This does not
preclude the submission of an application already reviewed with substantial
changes, but such application must include an “Introduction” addressing the
previous critique. Note that such an application is considered a
"resubmission" for the SF424 (R&R).

All NIOSH awards are subject to the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable. A
grantee may, at its own risk and without NIOSH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIOSH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIOSH approval before incurring
the cost. NIOSH prior approval is required for any costs to be incurred more
than 90 days before the beginning date of the initial budget period of a new
award.

The incurrence of pre-award costs in anticipation of a competing
award imposes no obligation on NIOSH either to make the award or to increase
the amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred.

NIOSH expects the grantee to
be fully aware that pre-award costs result in borrowing against future support
and that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See HHS Grants Policy Statement.

6. Other Submission Requirements and Information

Warning: Please be sure that you observe the direct cost,
project period, and page number limitations specified above for this FOA.
Application processing may be delayed or the application may be rejected if it
does not comply with these requirements.

PD/PI Credential (e.g., Agency
Login)

The NIH requires the PD/PI to
fill in his/her Commons User ID in the “PROFILE – Project Director/Principal
Investigator” section, “Credential” log-in field of the “Research & Related
Senior/Key Person Profile” component. The applicant organization must include
its DUNS number in its Organization Profile in the eRA Commons. This DUNS
number must match the DUNS number provided at CCR registration with Grants.gov.
For additional information, see “Registration FAQs – Important Tips -- Electronic
Submission of Grant Applications.”

Organizational DUNS

The applicant organization must
include its DUNS number in its Organization Profile in the eRA Commons. This
DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional information, see “Frequently Asked Questions –
Application Guide, Electronic Submission
of Grant Applications..”

Warning: Please be
sure that you observe the direct cost, project period, and page number
limitations specified above for this FOA. Application processing may be delayed
or the application may be rejected if it does not comply with these
requirements.

PHS398 Research Plan Component
Sections

All application instructions
outlined in the SF424 (R&R) Application Guide are to be followed,
incorporating "Just-in-Time" information concepts, and with the
following requirements for R21 applications:

Introduction (required for a resubmission or revision application)
is limited to 1 page.

Specific Aims is limited to 1 page.

Research Strategy, including tables, graphs, figures, diagrams,
and charts, is limited to 6 pages. See Table of Page
Limits.

Preliminary data are not required but may be included if
available.

Budget Component

R21 applications for this FOA will
use the non-modular budget formats and "Just-in-Time" information
concepts, with the total direct costs limitation of $275,000 over an R21
two-year period. No more than $200,000 in direct costs will be allowed in any
single year.

Only the review criteria described below will be considered in the
review process.

2. Review and Selection
Process

Applications submitted for this funding opportunity will be
assigned to NIOSH on the basis of established Public Health Service (PHS)
referral guidelines.

Applications that are complete will be evaluated for scientific
and technical merit by (an) appropriate scientific review group(s) in
accordance with NIH peer review procedures ( using the review criteria stated below.

INITIAL MERIT REVIEW

As part of the initial merit
review, all applications will:

Undergo a
selection process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under review, will be
discussed and assigned a rating;

Receive a
written critique; and

Receive a
second level of review by the appropriate national advisory council or board.

The
R21 exploratory/developmental grant supports investigation of novel scientific
ideas or new model systems, tools, or technologies that have the potential for
significant impact on biomedical or biobehavioral research. An R21 grant
application need not have extensive background material or preliminary
information. Accordingly, reviewers will focus their evaluation on the
conceptual framework, the level of innovation, and the potential to
significantly advance our knowledge or understanding. Appropriate justification
for the proposed work can be provided through literature citations, data from
other sources, or, when available, from investigator-generated data.
Preliminary data are not required for R21 applications; however, they may be
included if available.

The goals of NIOSH-supported
research are to advance our understanding of biological systems, to improve the
control of disease, and to enhance health. As part of this mission,
applications submitted to NIOSH for grants or cooperative agreements to support
the mission are evaluated for scientific and technical merit through the NIOSH
peer review system.
Overall Impact. Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following five core review criteria, and additional review criteria (as
applicable for the project proposed).

Core
Review Criteria. Reviewers will consider each of the five
review criteria below in the determination of scientific and technical merit,
and give a separate score for each. An application does not need to be
strong in all categories to be judged likely to have major scientific
impact. For example, a project that by its nature is not innovative may
be essential to advance a field.

Significance.Does the
project address an important problem or a critical barrier to progress in the
field? If the aims of the project are achieved, how will scientific
knowledge, technical capability, and/or clinical practice be improved?
How will successful completion of the aims change the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field?

Investigator(s).Are the
PD/PIs, collaborators, and other researchers well suited to the project?
If Early Stage Investigators or New Investigators, do they have appropriate
experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If
the project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation. Does
the application challenge and seek to shift current research or clinical
practice paradigms by utilizing novel theoretical concepts, approaches or
methodologies, instrumentation, or interventions? Are the concepts,
approaches or methodologies, instrumentation, or interventions novel to one
field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach.Are the
overall strategy, methodology, and analyses well-reasoned and appropriate to
accomplish the specific aims of the project? Are potential problems,
alternative strategies, and benchmarks for success presented? If
the project is in the early stages of development, will the strategy establish
feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done
contribute to the probability of success? Are the institutional support,
equipment and other physical resources available to the investigators adequate
for the project proposed? Will the project benefit from unique features
of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the
determination of scientific and technical merit, but will not give separate
scores for these items.

Protections for
Human Subjects. For
research that involves human subjects but does not involve one of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate the justification for involvement of human subjects and the proposed
protections from research risk relating to their participation according to the
following five review criteria: 1) risk to subjects, 2) adequacy of protection
against risks, 3) potential benefits to the subjects and others, 4) importance
of the knowledge to be gained, and 5) data and safety monitoring for clinical
trials.

For research that involves human subjects and meets
the criteria for one or more of the six categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials.

Inclusion of Women, Minorities, and Children.
When the proposed project involves clinical research, the committee will
evaluate the proposed plans for inclusion of minorities and members of both
genders, as well as the inclusion of children.

Vertebrate Animals.
The committee will evaluate the involvement of live vertebrate animals as part
of the scientific assessment according to the following five points: 1)
proposed use of the animals, and species, strains, ages, sex, and numbers to be
used; 2) justifications for the use of animals and for the appropriateness of
the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures
for limiting discomfort, distress, pain and injury to that which is unavoidable
in the conduct of scientifically sound research including the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and
5) methods of euthanasia and reason for selection if not consistent with the AVMA
Guidelines on Euthanasia.

Resubmission
Applications. When
reviewing a Resubmission application (formerly called an amended application),
the committee will evaluate the application as now presented, taking into
consideration the responses to comments from the previous scientific review
group and changes made to the project.

Renewal
Applications. Renewal applications are not allowed
under this funding opportunity announcement.

Revision
Applications. When reviewing a Revision application
(formerly called a competing supplement application), the committee will
consider the appropriateness of the proposed expansion of the scope of the
project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended
for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate
and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess whether materials or procedures proposed
are potentially hazardous to research personnel and/or the environment, and if
needed, determine whether adequate protection is proposed.

Additional Review
Considerations

Budget and Period of Support: The reasonableness of the
proposed budget and the appropriateness of the requested period of support in
relation to the proposed research may be assessed by the reviewers. The
priority score should not be affected by the evaluation of the budget.

Resource
Sharing Plan(s): Not required, however, when relevant, reviewers will be instructed
to comment on the reasonableness of the following Resource Sharing Plans, or
the rationale for not sharing the following types of resources. However,
reviewers will not factor the proposed resource sharing plan(s) into the
determination of scientific merit or priority score, unless noted otherwise in
the FOA. Program staff within NIOSH will be responsible for monitoring the
resource sharing.

Selection Process

Applications submitted in
response to this funding opportunity will compete for available funds with all
other recommended applications.

The following will be considered
in making funding decisions:

Scientific
and technical merit of the proposed project as determined by scientific peer
review.

After the peer review of the application is completed, the PD/PI
will be able to access his/her Summary Statement (written critique) via the NIH
eRA Commons (http://era.nih.gov/).

If the application is under consideration for funding, NIOSH will
request "just-in-time" information from the applicant. For details,
applicants may refer to Just-In-Time on www.cdc.gov/niosh/oep.

A formal notification in the form of a Notice of Award (NoA) will
be provided to the applicant organization. The NoA signed by the grants
management officer is the authorizing document. Once all administrative and
programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See SectionIV5, “Funding
Restrictions.”

We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research
(program), peer review, and financial or grants management issues:

Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

Inclusion of Persons Under the Age of 21 in Research

The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In the application, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.
The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

HIV/AIDS Confidentiality Provisions

Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.

Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.

To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.

If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.
Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National Prevention Information Network (NPIN). The website can be found at: http://www.cdcnpin.org/.

Patient Care

Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

A description of the population to be served.

A summary of the services to be provided.

A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

Paperwork Reduction Act Requirements

Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

Smoke-Free Workplace Requirements

HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at www.healthypeople.gov

Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent HHS/CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."

Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.

In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC 's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.

Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment

It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Proof of Non-profit Status

Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.

Security Clearance Requirement

All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.

Small, Minority, And Women-owned Business

It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

Place small, minority, women-owned business firms on bidders’ mailing lists.

Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.

Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.

Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

For example:
Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Compliance with Executive Order 13279

Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS. If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:http://www.whitehouse.gov/government/fbci/

Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:

In a timely manner.

Completely, and as accurately as possible.

To facilitate the broader community.

Developed in accordance with HHS/CDC policy on Releasing and Sharing Data.

Applications must include a copy of the applicant's Data Release Plan. Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Reviewers may consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking, shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register. The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

Conference Disclaimer and Use of Logos

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer. It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.